Enrich for the treatment of latent iron deficiency anemia and overt iron deficiency

Oral Drops :Elemental Iron 50 mg /ml
Syrup : Elemental Iron 10 mg/ ml

Composition :

Active Ingredient:
Enrich Oral drops
Each 1 ml contatns: Iron (lll) hydroxide Polymaltose complex 156.25mg (Eq. to 50 mg elemental iron)
Enrich.syrup                                                                                                  Each 1 ml contains: Iron (lll) hydroxide Polymaltose complex 31.25mg (Eq. to 10 mg elemental iron)
Inactive Ingredients:
Sorbitol Solution 70%, MethyI4-hydroxybenzoate, Propyl 4 -hydroxybenzoate, Ethanol 96%, Banana Flavor, Purified Water.

Pharmaceutical Form :

Enrich Oral drops (1 ml = 20 drops contains 50mg Iron)
Enrich Syrup (1 ml Syrup contains 10 gm Iron)

Therapeutic indications :

Treatment of latent Iron deficiency anemia (overt iron deficiency) . Iron deficiency and its extent must be secured and confirmed by appropriate diagnostic laboratory tests.

Dosage and Administration :

Daily dose in mg Iron
Manifest Iron deficiency     Deferred
Infants 1 year                 25-50mg                            15-25 mg
Children (1-12 years)    50-100 mg                        25-50 mg
Teenagers from 12 years and Adults 100-300 mg     50-100mg

**The daily dose can be divided into individual doses or all at once. The Enrich preparations should be taken during or immediately after eating. Enrich Syrup and drops can be mixed with fruit or vegetable juices, or with the formula. The light dose not effect color or taste effect. The dosage and duration will depend on the extent of iron deficit. In overt iron deficiency treatment lasts up to normalization of hemoglobin level on average 345 months. Subsequently, the treatment with each dose for latent iron deficiency continued for several weeks to replenish the iron stores. Treatment of latent iron deficiency takes 1-2 months.

Contraindications :

Known hypersenitivity to the drug or any of the excipients , iron overload (eg, hemochromatosis , hemosidrisls ) ,iron utilization disorders ( lead anemia , sideroachrestic anemia , thalassemia ), all anemias that are not caused by iron deficiency ( eg, hemolytic anemia)

Warnings and Precautions :

– Anemia should always be treated under medical supervision.
– if the success of therapy (increase in hemoglobin of 2-3 9 / dl after 3 weeks) fail, the treatment should be reconsider.
– For patients who receive repeated blood transfusions, caution is appropriate, since done with red cells, the flow of iron, which can lead to iron overload.

Interactions :

– Studies in rats with tetracycline, aluminum hydroxide, acetylsalicylate, sulfasalazine, Calcium Carbonate, calcium acetate, calcium phosphate in combination with vitamin 03, Bromazepam, magnesium aspartate, O-amino pencillin, methyldopa, paracetamol and auranofin showed no lnteraction.
– Interactions with food components such as phytic acid, Oxlaic acid, tannin, sodium, choline and choline, vitamin A, vitamin 03 and vitamin E, soy oil and soy meal were in vitro studies are not well established. These results suggest that Iron (lll) hydroxide polymaltose complex may be taken during or immediately after eating.
– Human studies (cross-over design) in 22 patients showed no significant reduction in the absorption of tetracycline. The time required for the effective plasma concentration of tetracycline
was not reached. Aluminum hydroxide and tetracycline decreased in human studies is not the absorption of iron (Ill) hydroxide polymaltose complex. Iron (Ill) hydroxide polymaltose complex can therefore be given with tetracycline or other phenolic compounds as well as with aluminum hydroxid

Pregnancy and lactation :

Animal studies showed no direct or indirect toxicity effect on pregnancy, embryonic and fetal development.
data in limited number of pregnant women after the first trimester showed no adverse effects on pregnancy or the health of the fetus or newborn Breast milk naturally contains iron bound to lactoferrin. How much iron from Enrich preparations in the breast milk is not known. It is unlikely to taking these drugs may cause unwanted effects in breast-fed child. Enrich preparations should be used during pregnancy and lactation only after consultation with the doctor.

Effect on the ability to drive and use machines :

There have been no studies. However, it is unlikely that Enrich has an effect on the ability to drive and use machines.

Adverse effects :

The following side effects have been reported with the administration of Enrich:
Immune system: Very rare: allergic reaction, urticaria, asthma.
Nervous system: Uncommon: headache.
Gastrointestinal tract:
Common: nausea, consistency of stool.
Uncommon: abdominal pain, upset stomach, dyspepsia, vomiting. diarrhea, reversible tooth discoloration.
Skin: Very rare: pruritus, rash, localized skin reactions.
Kidney and urinary tract: Urine: dark urine
Note: There are often a fecal discoloration, which is caused by iron precipitation.

Overdose :

In the case of overdose has neither intoxication nor iron overload has been observed since the iron in the active iron (lll) hydroxide polymaltose complex in the gastrointestinal tract is not as free iron
is present and not absorbed by diffusion in the organism. Known overdose symptoms of other iron supplements (iron [11] salt), such as: blood pressure, shock, metabolic acidosis, coma and convulsions have not been reported until now

Properties / Effects :

Mechanism of action: The iron is used to form hemoglobin.
like all iron preparations Enrich has neither an effect on erythropoiesis by himself, to anemta, which is not caused by iron deficiency ..
Pharmacodynamics: The absorbed iron is mainly stored in the liver, where it is bound to ferrritin  later it will be integrated in the bone marrow into hemoglobin.

Pharmacokinetics :

Absorption and Distribution:
Studies with radioactively labeled iron (Ill) hydroxide polymaltose complex show that the absorption, ie the proportion of iron, which is incorporated into hemoglobin, is inversely proportional to dose .. The amount of iron absorbed depends on the degree of iron deficiency (the larger the deficit the higher the iron absorption) in therapeutic use of Enrich the absorption is  approximately 10% Enrich is in the small intestine, recorded mainly in the duo enum and the jejunum. At least at the start of treatment, the iron from iron (Ill) hydroxide complex polymaltose is less bioavailable than in preparations with iron (ll)
Metabolism and Elimination: Non-absorbed iron is excreted in faeces.

Package and Storage :

– Enrich Syrup: Carton Box containing a Brown glass bottle type III of 100 rnl & insert leaflet
– Enrich Oral Drops: Carton Box containing a Brown glass bottle type III of 30 ml with a dropper & insert leaflet
– Store at temperature not exceeding 300 C and store in its original packaging.
– Keep out of reach of children.

Manufactured by :

Marcyrl Pharmaceutical Industries
El Obour City – Egypt

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